Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy

September 19, 2007 updated by: Cytos Biotechnology AG

Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (CYT005-AllQbG10) in Subjects With Seasonal Rhinoconjunctivitis Due to Grass-Pollen Allergy

The purpose of this study is to evaluate whether the use of a specific immunomodulatory principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and more pronounced decrease of sensitivity against pollen than with the grass pollen allergen alone

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8091
        • University Hospital of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 65 years of age
  • Mild to moderate seasonal allergic rhinoconjunctivitis due to sensitization against grass pollen as evident from history (≥ 2 years), and positive nasal provocation test (NPT) and positive skin prick test (SPT, wheal ≥ 3mm larger than diluent) to grass pollen extract
  • Female participants must meet one of the following criteria:

No reproductive potential due to menopause (one year without menses, in case of doubts serum FSH will be determined and must be >40 U/mL), hysterectomy, bilateral oophorectomy, or tubal ligation. Patient agrees to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 1 additional months after the last immunization (hormone-based, or intrauterine device, or double barrier contraception, i.e. condom + diaphragm, condom or diaphragm + spermicidal gel or foam)

  • Written informed consent
  • Patient is willing and able to comply with all trial requirements

Exclusion Criteria:

  • Additional allergies (seasonal or perennial) of which the symptoms overlap temporally with the screening and treatment period
  • Contraindication to Allergen Preparation
  • Contraindication for Nasal Provocation Test
  • Contraindication for Skin Prick Test
  • Actual significant obstructive pulmonary disorder (FEV1< 70%)
  • Pharmacological treatment that could affect allergic sensitivity during the trial
  • Presence or history of significant cardiovascular, renal, pulmonary, endocrine, autoimmune, neurological, and psychiatric disease as judged by the investigator
  • Serum test positive for HIV, HBV, or HCV
  • Current diagnosis or history of malignancy; presence of suspicious lymphadenopathy or splenomegaly on physical examination
  • Pregnancy or lactation
  • Blood donation within 30 days before enrolment
  • History of abuse of alcohol or other recreational drugs
  • Specific immunotherapy against pollen allergy within the last two years
  • Intake of an investigational drug within three month before enrolment
  • Intake of contraindicated medicaments for SIT as Betablockers, ACE/ATII Inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Nasal Provocation Tests

Secondary Outcome Measures

Outcome Measure
Allergy and Medication Questionnaires

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytos Biotechnology AG

Investigators

  • Principal Investigator: Gabriela Senti, MD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

September 20, 2007

Last Update Submitted That Met QC Criteria

September 19, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYT005-AllQbG10 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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